Drug product
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
D-532-2013
Product summary
- Firm
- TG United, Inc.
- Event
- Event 64188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 386 - 1000-count bottles
- Official record key
drug-enforcement:D-532-2013
Official wording
Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Code information: Lot# 11A006 Exp 12/12; Lot# 11A007 Exp 12/12; Lot# 11G004 Exp 06/14; Lot# 11G005 Exp 06/14; Lot# 12C004 Exp 02/14; Lot# 12F007 Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009 Exp. 05/14; Lot# 12G005 Exp 06/14.
Distribution pattern: FL, MS, SC, LA and TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations